New rules set to boost paediatric medicine research
Testing medicines for paediatric use will lead to six-month patent
extensions |
Final agreement has been reached on European rules intended to encourage proper testing and licensing of medicines for paediatric use.
The new rules, in the form of a European Regulation, are expected to
become law before the end of the year. Unlike EU Directives — which
have to be transposed into national legislation — European Regulations
come into force immediately they are published in the Official Journal
of the European Communities
In order to encourage proper testing of medicines for paediatric use,
companies that carry out such tests will be able to have the patents
for such medicines extended by six months, regardless of whether or not
the tests show that paediatric use is safe.
There will also be special funding to encourage generics companies to
test off-patent medicines for paediatric use.
Health minister Rosie Winterton said: “The UK has been a strong
advocate for such measures for a number of years and this legislation
was a key priority during the UK presidency of the EU. This regulation
will help to ensure that we have safe and effective medicines specifically
formulated for children and I am pleased that this important step has
now been taken.”
Kent Woods, chief executive of the Medicines and Healthcare products
Regulatory Agency, added: “This is an important step to make medicines
for children safer and the MHRA welcomes this development. The new regulation
will ensure that medicines will be available to children in appropriate
formulations.”
The agreement has been welcomed by the Neonatal and Paediatric Pharmacists
Group. NPPG chairman Ian Costello said: “This regulation is a significant
development in the provision of appropriate medicines for children. Together
with other recent initiatives, such as the MHRA/Department of Health
strategy on medicines for children and the Medicines for Children Research
Network, it provides an environment in which evidence on safe and effective
drug treatments for children, and appropriate formulations, can be developed.
We hope this opportunity will be grasped and look forward to the pharmaceutical
industry, researchers and practitioners working together to make this
a reality.” |
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